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Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy (DILANA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04094454
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

Brief Summary:
A commercially available vaginal dilator set will be used as measuring device. The grading of vaginal stenosis will be determined as difference of the diameter of vaginal dilator to the baseline. A reduction of the diameter of <20% is defined as vaginal stenosis Grade 1, a reduction of 20-35% as Grade 2, a reduction of >35-49% as Grade 3 and a reduction >/=50% as Grade 4. The investigators hypothesize that the rate of vaginal stenosis Grade 1 or higher 12 months after radiotherapy is lower in the group using extended vaginal dilation during radiotherapy (Arm A). Rates of vaginal stenosis of 50% have been observed in previous patient collectives and the investigators hypothesize that a reduction to 25% is possible in the experimental group.

Condition or disease Intervention/treatment Phase
Anal Cancer Device: special tampon with a diameter of 28mm Device: standard tampon with a diameter of 12-13mm Not Applicable

Detailed Description:
The study is designed as a prospective, randomized, two-armed, single-center phase-II-trial. 60 patients will be included in the study. Patients fulfilling the inclusion criteria will be randomized into one of the two arms, which differ only in the diameter of a tampon used for vaginal dilatation during treatment. All patients will receive standard (chemo)radiotherapy with a total dose of 45-50,4 Gy (single dose 1,8-2 Gy) to the pelvic and inguinal (if required) lymphatic drainage with a boost to the anal canal up to 54-60 Gy (single doses 1.8-2.2 Gy). The primary objective is the assessment of the incidence and grade of vaginal fibrosis 12 months after (chemo)radiotherapy for anal cancer depending on the extent of intrafractional vaginal dilatation. Secondary endpoints are clinical symptoms and toxicity according to the Common Toxicity Criteria (CTC) version 5.0, assessment of clinical feasibility of daily use of a tampon for vaginal dilatation, assessment of the compliance for the use of a vaginal dilatator and quality of life assessed with the EORTC-QLQ30/-ANL27 questionnaires.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy - Prospective, Randomized, Two-armed Phase-II-study
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

Arm Intervention/treatment
Experimental: Tampon with extended vaginal dilatation
Patients in arm A will use a special tampon with extended vaginal dilatation during radiotherapy
Device: special tampon with a diameter of 28mm
patients will use a special tampon with extended vaginal dilatation (diameter 28mm) during radiotherapy

Active Comparator: Commercially available tampon
Patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy
Device: standard tampon with a diameter of 12-13mm
patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy




Primary Outcome Measures :
  1. incidence and grade of vaginal fibrosis [ Time Frame: Up to 12 months after start of (chemo)radiotherapy ]
    during and after radiotherapy, clinical symptoms are assessed and graded


Secondary Outcome Measures :
  1. clinical symptoms and toxicity according to the CTC AE version 5.0. criteria [ Time Frame: weekly during radiotherapy, at each follow-up visit ]
    during and after radiotherapy, clinical symptoms are assessed and graded according to the CTC AE v5.0 criteria

  2. clinical feasibility of daily use of a special tampon [ Time Frame: continously during radiotherapy ]
    daily assessment of the clinical feasibility of daily use of a special tampon

  3. assessment of the compliance for the use of a vaginal dilatator [ Time Frame: continously at every follow-up visit ]
    patients will be instructed to use a vaginal dilator 3 times a week, at each follow-up visit patients are asked about the frequency of vaginal dilator use

  4. assessment of quality of life [ Time Frame: baseline, 6-8 weeks after and 6/12 months after finishing radiotherapy ]
    EORTC-QLQ30/-ANL27 questionnaires are used to assess quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patient
  • Histologically confirmed squamous anal cancer
  • Indication for definitive or postoperative radiotherapy
  • ECOG 0-2
  • Age > 18 years
  • Written informed consent

Exclusion Criteria:

  • patients refusal or incapability of informed consent
  • no vaginal dilatation possible prior to radiation treatment start
  • prior pelvic irradiation (if direct field border or even overlap of radiation fields assumed)
  • participation in another clinical trial which might influence the results of the DILANA trial
  • pregnancy/nursing period or inadequate contraception in women with child bearing potential

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04094454


Contacts
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Contact: Nathalie Arians, MD +49 6221 568202 nathalie.arians@med.uni-heidleberg.de
Contact: Matthias Haefner, MD +49 6221 568202 matthias.heafner@med.uni-heidelberg.de

Locations
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Germany
University Hospital of Heidelberg, Radiation Oncology Recruiting
Heidelberg, Germany, 69120
Contact: Jürgen Debus, Prof. Dr.    +49-6221-56 ext 8202    juergen.debus@med.uni-heidelberg.de   
Contact: Adriane Hommertgen    +49-6221-56 ext 8202    adriane.hommertgen@med.uni-heidelberg.de   
Sponsors and Collaborators
Juergen Debus
Investigators
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Principal Investigator: Nathalie Arians, MD University Hospital Heidelberg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Juergen Debus, Principal Ivestigator, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT04094454    
Other Study ID Numbers: RADONK-DILANA-2018
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juergen Debus, University Hospital Heidelberg:
female patients
quality of life
vaginal dilator
vaginal fibrosis
Additional relevant MeSH terms:
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Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Anus Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases